Allograft Process Engineer: From R&D to GMP Manufacturing

ClinLab Solutions Group; San Antonio (TX); On-site; USD 80,000 - 110,000; Full time

Job summary

ClinLab Solutions Group seeks a Project Engineer to advance allograft product development within a regulated environment. You will lead processing activities, design experiments, analyze data, and prepare technical reports to support regulatory requirements.

The role emphasizes transfer of R&D processes to production, protocol development, and maintaining compliant documentation. Collaboration with manufacturing and quality teams is essential to drive quality and innovation.

Qualifications

• Bachelor’s or Master’s degree in Biology, Biomedical Engineering, Biomedical Sciences, or related field.
• Experience in process development, manufacturing, analytical testing, and/or quality systems for allograft (hands-on preferred).
• Proficiency in designing and executing protocols for qualification and validation activities.
• Exceptional communication and problem-solving skills.
• Comprehensive knowledge of GMP, FDA, and AATB regulatory requirements.
• Strong organizational skills with experience in documentation, data tracking, and regulatory compliance.
• Prior tissue banking and/or wet lab experience, as well as industry experience, strongly preferred.

Responsibilities

• Lead and execute allograft processing activities, including tissue characterization and process troubleshooting.
• Design and implement experimental protocols, analyze data, and prepare comprehensive technical reports.
• Optimize and validate manufacturing processes to ensure adherence to quality standards and regulatory requirements.
• Train and support manufacturing teams in transferring R&D processes to production, including qualifications and post-launch improvements.
• Maintain detailed experimental records and draft technical documentation such as SOPs, protocols, and regulatory submissions.
• Ensure compliance with FDA, AATB, and GMP standards throughout product development and manufacturing processes.
• Monitor advancements in allograft technologies and contribute to ongoing innovation within the field.
• Uphold ethical business practices and maintain compliance with all relevant laws, regulations, and internal policies.

Skills

Process development

Manufacturing

Analytical testing

Quality systems

Regulatory knowledge

Documentation

Communication

Problem solving

Education

Bachelor’s/Master’s in Biology/ Biomedical Eng

Job description

ClinLab Solutions Group seeks a Project Engineer to advance allograft product development within a regulated environment. You will lead processing activities, design experiments, analyze data, and prepare technical reports to support regulatory requirements.

The role emphasizes transfer of R&D processes to production, protocol development, and maintaining compliant documentation. Collaboration with manufacturing and quality teams is essential to drive quality and innovation.